Job Information
Sartorius Product Compliance Expert in Beijing, China
Product Compliance Expert will be responsible for ensuring and executing the product regulatory compliance of Instruments and Systems during development and life cycle management (product maintenance / changes) for launch readiness.
Product Compliance Expert will be responsible for ensuring and executing the product regulatory compliance of Instruments and Systems during development and life cycle management (product maintenance / changes) for launch readiness.You will organize regulatory information for the assigned countries/regions, oversee required tests, facilitate risk assessments, track and control submissions, provide guidance and advice to internal stakeholders.
Main Responsibilities & Tasks:
You will manage the activities of product compliance of assigned projects/products within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
You will provide product regulatory compliance input to strategic decision making, including review, prioritization, risk assessment and external communications
You will support the development and deployment of global policies and standards
You will manage tests with external laboratories as well as successful submissions with regulatory authorities
You will plan, undertake and oversee regulatory inspections, liaise and negotiate with global regulatory and certification authorities
You will provide advice about regulations to project team members and will review and report overall quality status
You will keep up-to-date with changes in regulatory legislation and guidelines
You will support your direct manager with continuous improvement initiatives to ensure the products and processes comply with regulatory requirements
Perform regulatory compliance assessment for assigned products to ensure the compliance in target market and maintain compliance based on assessment
Qualification & Skills:
Bachelor´s or Master's degree in science within a relevant scientific discipline required
Several years relevant experience within the Regulatory Affairs discipline and deep knowledge of the relevant Regulatory requirements
Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations like Chinese pressure vessel regulation (TSG 21-2016)
Manage the activies of APAC market access requirements ， including China CML certification ， CCC ， RoHS ， DOSH ， KCs ， etc
Knowledge of global certification requirements would be an added benefit
Experienced in developing innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
Proven analytical skill and technical/scientific competence
Attention to details and ability to appropriately assess risks
Excellent communication skills, with ability to influence others and negotiate successful outcomes
Proactive, pragmatic, quick learner and independent worker able to effectively multi-task in a strongly growing organization
Proven ability to effectively work collaboratively in cross functional teams
Excellent written and verbal communication skills and fluency in English
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers